A month after scoring $1.6 billion from the U.S. government, Novavax is posting the first human data from its COVID-19 vaccine. The early results, from the phase 1 part of a phase 1/2 study, show that two dose levels of the recombinant vaccine triggered an immune response similar to those in patients who had recovered from the disease.
The study tested four dose regimens of the vaccine, NVX-CoV2373, against placebo in 131 healthy adults up to 59 years old. Although it tested an unadjuvanted form of the vaccine and a single-dose regimen of the adjuvanted vaccine, all eyes were on two adjuvanted regimens: 5 micrograms and 25 micrograms given in two injections three weeks apart.
All of the patients developed neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19, but those who received two doses of the adjuvanted vaccine did the best. At the 35-day mark, or two weeks after their second dose, they had neutralizing antibody levels higher than those seen in a group of patients who had recovered from COVID-19. What’s more, the lower dose fared “comparably” to the higher dose.
Zydus Starts Phase 2 COVID-19 Vaccine Trial After Clearing Safety Test
Zydus Cadila has completed a phase 1 clinical trial of its COVID-19 vaccine ZyCoV-D, setting it up to move straight into a 1,000-subject phase 2 study. The Indian company said the DNA vaccine was well tolerated in the first stage of the adaptive phase 1/2 trial it initiated last month.ZyCoV-D is designed to introduce DNA that encodes for a viral protein into human cells. By ordering human cells to make the protein, ZyCoV-D could elicit an immune response against the coronavirus. The approach is similar to that pursued by Inovio Pharmaceuticals. Like Inovio, Zydus sees the ability of its vaccine to withstand higher temperatures than some rival approaches as a differentiator.
Whether ZyCoV-D works as well as other COVID-19 vaccine candidates remains to be seen. So far, Zydus has only said that the vaccine was well tolerated by people who received it in the first phase of the trial. Zydus monitored subjects in a clinical pharmacological unit for 24 hours after dosing and in the community for seven days thereafter. Based on the safety profile seen so far, which Zydus said was endorsed by the Data Safety Monitoring Board, the study is set to progress into its larger, 1,000-subject, placebo-controlled phase 2 portion on Thursday.